New Delhi, 14th Sep, 2017: In a letter to Shri Bhupendra Singh, Chairman, NPPA, Association of Indian Medical Device Industry (AiMeD) has applauded the decision of NPPA for bringing the much needed respite in the sector by controlling the pricing of Drug Eluting Stents and bare metal Stents.

“We believe that the biggest winner from the NPPA order is the common citizen who now has an access to the best products at the most affordable prices. We would like to sincerely thank the Central Government of India, Ministry of Chemical and Fertilizers, Department of Pharmaceuticals and NPPA for this huge step towards making these essential products available across the country at affordable prices and thus boosting the idea of domestic manufacturing, increasing the market size and also for providing a level playing field for the Indian Manufacturers.” Said Mr Rajiv Nath, Forum Coordinator, AiMeD.

“NPPA has also remained extremely considerate towards not squeezing the manufacturer’s margins any further which are now needed towards R&D and other expenses related to generating Patient Safety Studies and Clinical Evaluation. The ceiling price was supported by order on controlling the distributor and Hospital margins to 8% ensuring that the trade practices become transparent and ethical.” Added Mr Nath.

The manufacturing of Drug Eluting Stents (DES), a commonly used medical implant during the procedure of Angioplasty(for treating Heart Attacks), has gone through tough times in India. The stent industry for over 2 decades was dominated mainly by large American Multinationals Companies(MNC’s) and was highly dependent on import of the same until the domestic manufacturers came in business and took initiative to start manufacturing cardiovascular implants and Devices of proven high quality.

It was anticipated that the indigenous products would contribute to low dependence on the imported products but the same were put at rest because of the following problems:

i. The hospitals and doctors created an image that the Multinational products are better in terms of their efficacy and safety. The MNC’s allured the distributors and hospitals with high margins and the ultimate cost for the patient became very high.

ii. There were many government tenders where the Indian companies couldn’t participate as the same had specifications demanding a USFDA product. There are Indian products which were clinically proven to be equally efficacious to the multinational products also lagged behind because of these specifications.

iii. The Indian manufacturers were not able to match up to the margins the MNC’s were able to offer as they did not have problem in investing more and more on developing their trade channels instead of local manufacturing.

The Make in India initiative launched by Honorable Prime Minister, Shri Narendra Modi in September 2014 as part of a wider set of nation-building initiatives was devised to transform India into a global design and manufacturing hub, which was a timely response to a critical situation. The initiatives provided the much needed booster for the Medical Device sector with ease of doing business becoming the major enabler. The important sector of High End Medical Devices in which there is more than 75% import dependency, also was positively impacted.

“In the last six months, we have seen a positive trend towards increased sales for domestic manufacturers. This is more so in Tier 2 & Tier 3 towns due to higher affordable access post reduction of prices. We estimate that this trend shall continue and boost the idea for manufacturing of DES in India.” Said Mr Rajiv Nath.

One of the real eye-openers for the Hospitals was when American companies decided to withdraw their “New generation DES” from the market. The companies which the Hospitals supported for the last 20-25 years wanted to leave them high and dry for the want of more profits. The Indian manufacturers came as saviors and offered their best technologies within the Ceiling prices. The Domestic manufacturers increased their production to meet the demand of the Hospitals.

“There are some news about the loss to companies and how the whole business of DES manufacturing is becoming unviable. We are ready to come to a common platform to debate and prove that the NPPA order has rather helped the companies to improve margins and if somebody has lost the profitability, it’s only the middlemen and Hospitals.” Added Mr Nath.

“The Indian manufacturers reaffirm their commitment to progressively provide the best technologies to Indian patient at most affordable prices.” He further added.